Download Field Service Manual Rev-01

Medtronic CryoCath LP Technical Reference Manual
(For Hospital Biomedical Engineers)
TRM-002 MDT.2 CryoConsole
Rev-00
Manufacturer:
Medtronic CryoCath LP
16771 Chemin Ste-Marie
Kirkland, Quebec, Canada
H9H 5H3
Tel: (514) 694 1212
Fax: (514) 694 7075
TRM-002 MDT.2 CRYOCONSOLE – GEN IV
Rev-00
TABLE OF CONTENTS
SECTION I
I.1
I.2
I.3
I.4
I.5
I.6
PURPOSE ........................................................................................................................................... 5
SCOPE ............................................................................................................................................... 5
DEFINITIONS AND ACRONYMS ......................................................................................................... 5
WARNINGS/PRECAUTIONS ............................................................................................................... 6
GENERAL DESCRIPTION ................................................................................................................... 7
TECHNICAL SPECIFICATIONS ......................................................................................................... 13
SECTION II
II.1
II.2
II.3
II.4
II.5
II.6
II.7
GENERAL INFORMATION....................................................................................... 5
FUNCTIONAL SYSTEM DESCRIPTION .............................................................. 17
PURPOSE .................................................................................................................................... 17
SCOPE ........................................................................................................................................ 17
DEFINITIONS AND ACRONYMS................................................................................................... 17
SYSTEM OVERVIEW ................................................................................................................... 17
SOFTWARE INTERFACE .............................................................................................................. 18
MECHANICAL SYSTEM............................................................................................................... 20
ELECTRICAL SYSTEM................................................................................................................. 21
SECTION III
OPERATION AND CLINICAL SEQUENCE ......................................................... 22
SECTION IV
TROUBLESHOOTING AND MAINTENANCE..................................................... 22
IV.1
IV.2
IV.3
IV.4
IV.5
PURPOSE .................................................................................................................................... 22
SCOPE ........................................................................................................................................ 22
DEFINITIONS AND ACRONYMS................................................................................................... 23
MAINTENANCE .......................................................................................................................... 23
SOFTWARE INTERFACE .............................................................................................................. 27
APPENDIX A– SYSTEM NOTICES...................................................................................................... 31
APPENDIX B– ADDITIONAL WARNING MESSAGES ................................................................... 39
APPENDIX C– GUIDELINE & SPECIFICATIONS FOR N2O REFILLING .................................. 40
Medtronic CryoCath LP
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Index of Figures
Figure 1 - The CryoConsole Gen III and Accessories ..................................................................7
Figure 2 - The CryoConsole Gen IV and Accessories ..................................................................8
Figure 3 - North American tank and European tank .....................................................................8
Figure 4 - The CryoConsole Gen III features ..............................................................................10
Figure 5 - The CryoConsole Gen IV features .............................................................................10
Figure 6 - Foot switch connector.................................................................................................11
Figure 7 - Main panel ..................................................................................................................23
Figure 8 - System Setup panel ...................................................................................................24
Figure 9 - Password panel ..........................................................................................................24
Figure 10 - System Maintenance panel ......................................................................................25
Figure 11 - Password Setup panel..............................................................................................25
Figure 12 - Date & Time Setup panel .........................................................................................25
Figure 13 - Site Setup panel .......................................................................................................26
Figure 14 - Backup Patient Files panel .......................................................................................26
Figure 15 - Floppy Drive .............................................................................................................27
Figure 16 - Message List ............................................................................................................28
Figure 17 - Danger and Warning System Notice ........................................................................29
Figure 18 - Caution and Notice System Notice...........................................................................29
Medtronic CryoCath LP
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TRM-002 MDT.2 CRYOCONSOLE – GEN IV
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Index of Tables
Table 1 - CryoConsole Specifications.........................................................................................13
Table 2 - Accessories Specifications ..........................................................................................15
Table 3 - Notice series ................................................................................................................30
Medtronic CryoCath LP
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TRM-002 MDT.2 CRYOCONSOLE – GEN IV
Rev-00
THIS MANUAL
DOES NOT REPLACE THE OPERATOR’S MANUAL, ITS APPENDICES,
AND THE INSTRUCTIONS FOR USE FOR EACH RESPECTIVE CATHETER.
THE TERM CATHETER IS USED THROUGHOUT THIS MANUAL TO DESCRIBE BOTH
CARDIAC CRYOABLATION CATHETERS AS WELL AS SURGICAL CRYOABLATION
DEVICES.
Medtronic CryoCath LP
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TRM-002 MDT.2 CRYOCONSOLE – GEN IV
Section I
I.1
Rev-00
General Information
Purpose
The purpose of this section is to give general information of the CryoConsole functionality,
characteristic and accessories available.
I.2
Scope
This manual applies to the Medtronic CryoCath LP MDT.2 CryoAblation System Gen III (North
American Ref#103A2, European Ref#103E2) as well as Gen IV system (North American
Ref#104A2, European Ref#104E2). The CryoAblation Data Manager versions supported by this
manual are 3.03 and 3.04.
I.3
Definitions and Acronyms
The following definitions and acronyms are used in this section:
MDT
IEC
ISO
UL
TLV
NIOSH
ECG
CSA
MDD
LRQ
7F/9F
CE
Sccm
PSIa
KPa
Medtronic CryoCath LP
Medtronic CryoCath LP
International Electro technical Commission
International Organization for Standardization
Underwriters Laboratories
Threshold Limit Value
National Institute for Occupational Safety and Health
Electrocardiogram
Canadian Standards Association
Medical Device Directive
Lois Refondues du Québec
7 French / 9 French
Conformité Européenne
Standard Cubic Centimeters per Minute
Pound per Square Inch Absolute
Kilopascal
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TRM-002 MDT.2 CRYOCONSOLE – GEN IV
I.4
Rev-00
Warnings/Precautions
DO NOT ATTEMPT to service the MDT.2 CryoConsole.
Only technicians, fully trained by MDT, can service the CryoConsole.
Training courses and custom made tools are available at MDT.
Only the catheters, accessories, gas cylinders and spare parts that have been obtained
from Medtronic CryoCath LP are to be used with the CryoConsole.
Even though the CryoConsole has passed the requirements of IEC 601-1 (UL report 75HN) it is
the user’s responsibility after installation and maintenance to verify and ensure that the
CryoConsole meets the applicable electrical safety requirements.
Electrical Safety Test
Test performed by:
Print Name
Medtronic Field
Engineer
Hospital BioMedical
Engineer
Signature
Date (yyyy.mm.dd)
Nitrous Oxide Usage
¾
The MDT.2 CryoConsole operates on high-pressure liquid N2O delivery. Store and handle
the N2O cylinder according to hospital gas management policy. Make sure to know their
location for future needs.
¾
When using the CryoConsole during a procedure or during servicing, Nitrous oxide (N2O)
must be safely vented through the connected scavenging according to policies &
procedures of each hospital in each country. Refer to the MDT.2 CryoConsole Operator’s
Manual for proper venting as described in Section IV – CryoConsole Pre-procedure set-up.
¾
Use only N2O tanks supplied by Medtronic CryoCath LP.
¾
Use only Medtronic CryoCath LP supplied scavenging hose.
¾
Do NOT restrict or kink the scavenging hose.
¾
Do NOT disconnect the catheter or the scavenging hose from the MDT.2 CryoConsole until
ALL N2O is safely vented from the system (a few seconds after the end of the last
injection).
¾
Cylinders are NOT for use on any other equipment.
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TRM-002 MDT.2 CRYOCONSOLE – GEN IV
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¾
Threshold Limit Value (TLV) for N2O is 25ppm as recommended by the National Institute
for Occupational Safety and Health (NIOSH).
¾
Exposures to N2O should be minimized to prevent short-term behavioural and long-term
reproductive health effects.
¾
Do not open the N2O gas tank valve until it is properly connected and tightened to the
CryoConsole.
¾
Do not disconnect the high-pressure lines from the cylinder until the pressure gauges read
‘0’ psi. Close the N2O gas tank valve and allow the N2O to safely vent from the system and
lines, by turning the vent valve on the tank side couterclockwise, before disconnecting the
high-pressure lines.
I.5
General Description
The Medtronic CryoCath LP CryoAblation System consists of three principal components:
¾
¾
¾
MDT.2 CryoConsole with CryoAblation Data Manager software
The selected CryoAblation catheter
Supplies and Accessories, including:
o Sterile/single use Coaxial Umbilical
o Sterile/single use Electrical Umbilical
o Non-sterile Auto Connection Box
o Non-sterile ECG Cable
o Gas Scavenging Hose
o Refrigerant Tank (N2O cylinder)
o Power Cord
o Foot switch (Optional)
Figure 1 - The CryoConsole Gen III and Accessories
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TRM-002 MDT.2 CRYOCONSOLE – GEN IV
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Figure 2 - The CryoConsole Gen IV and Accessories
Note: Figure 1 and Figure 2 show the North American set-up (Nitrous Oxide tank)
The European tank differs from the North American tank in size, weight and capacity. Figure 3
shows the visual difference between the two.
North American tank
European tank
Figure 3 - North American tank and European tank
The CryoConsole only operates in temperatures between 15°C and 30°C (60°F and 86°F), an
altitude ranging from sea level to 2400 meters (8000 feet), and at a maximum humidity of 75%.
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I.5.1. Description of the System
MDT.2 CryoConsole
The CryoConsole Gen III reference (103A2 and 103E2) is a type CF, 115/230v, 50/60Hz, 10amp,
with respect to electric shock, fire, mechanical hazards in accordance with UL 2601-1: 1997 and
CAN/CSA C22.2 No. 601.1, control number 75HN and IEC #601-1.
The CryoConsole Gen IV model (104A2 and 104E2) is a type CF, 115/230v, 50/60Hz, 10amp,
with respect to electric shock, fire, mechanical hazards in accordance with CAN/CSA C22.2 No.
601.1-M90 file #220418 and IEC #601-1:1998.
Medtronic CryoCath LP recommends that the biomedical engineer of the site perform regular
electrical leakage current measurements in order to ensure that the system leakage current does
not exceed the allowable current as required by the applicable standards (IEC #601-1).
The CryoConsole houses the electrical, mechanical components and the software for controlling
and recording the CryoTherapy procedure. It stores and controls delivery of liquid N2O under
high pressure through the coaxial umbilical to the catheter, recovers the refrigerant vapour from
the catheter under vacuum, and disposes the refrigerant through the hospital scavenging system.
Pressurized liquid N2O is delivered from the
CryoConsole through an ultra fine, robust
injection tube, to the tip of the catheter
Inside the tip, the liquid N2O
vaporizes as it encounters heat
from the surrounding tissue
Medtronic CryoCath LP
The
CryoConsole
has numerous
safety systems
to prevent any
potential
hazards
The warmed
vapor is
returned to the
CryoConsole
through a
lumen
maintained
under vacuum
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TRM-002 MDT.2 CRYOCONSOLE – GEN IV
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Figure 4 - The CryoConsole Gen III features
Pressurized liquid N2O is delivered from the
CryoConsole through an ultra fine, robust
injection tube, to the tip of the catheter
Inside the tip, the liquid N2O
vaporizes as it encounters heat
from the surrounding tissue
The
CryoConsole
has numerous
safety systems
to prevent any
potential
hazards
The warmed
vapor is
returned to the
CryoConsole
through a
lumen
maintained
under vacuum
Figure 5 - The CryoConsole Gen IV features
The hardware controls the safety monitoring system while the software provides the interface to
the patient information, procedure temperature, temperature set point, time set point and
procedure data information.
Numerous safety systems exist to control the safe delivery of liquid N2O to the catheter and the
return of the vapour.
1. Inside the catheter
Vacuum System ....... The shaft is always under vacuum unless blood is detected.
Leak Detection .......... The leak detector detects blood ingress.
2. At the catheter handle
Blood Detection......... An infrared sensor inside the handle detects blood.
3. Inside the CryoConsole
Flow Detection .......... The system monitors the flow of the returned N2O vapour and will
shut off the injection if the flow is outside the parameterized range.
Fluid Detection .......... An ultrasound detector will disable the system if fluid is detected
inside the console vacuum line.
Vent System.............. The vent system sucks back the refrigerant.
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When pushing the “Injection On” button for 2 second, the button lights up green, and the
refrigerant injection begins. Injection stops when the red “Injection Off” button is pressed, when
the timer runs out or when a system notice is triggered.
I.5.2. Accessories
The accessories include a sterile single use coaxial umbilical, a sterile single use electrical
umbilical, an auto connection box and an ECG cable. During a medical intervention, the nonsterile accessories must be handled in such a way not to introduce them into the sterile field.
The electrical umbilical provides the electrical connection between the CryoConsole and the
catheter through the auto connection box. The coaxial umbilical provides the refrigerant during
injection and recovers the vapour from the catheter to the CryoConsole. The auto connection box
and the ECG cable provide an interface between the catheter and a standard EP system.
The auto connection box has a mechanical relay that automatically connects the thermocouples
upon injection and disconnects them when injection stops and the temperature at the distal end of
the catheter reaches 32°C or above. The purpose of this feature is to reduce the noise
superimposed on the intra-cardiac signal recording.
I.5.2.1.
Optional Accessory
The foot switch serves as a remote control to start and stop the injection. The injection
will start if the foot switch is pressed for more than 2.5 seconds. To stop the injection, the
switch must be pressed for 0.5 second. The foot switch connector is located on the
bottom back of the CryoConsole as shown in Figure 6. Using the foot switch does not
change the functionality of the injection button. The reference number for the Gen III
footswitch is 103FS and the reference number for the Gen IV footswitch is 104FS.
Foot switch
connector
Figure 6 - Foot switch connector
I.5.2.2.
Connection Sequence
Connect the scavenging hose, the power cord and the optional foot switch (if applicable).
To connect the accessories in preparation for a case, first connect the non-sterile
accessories to the CryoConsole:
¾
¾
Auto connection box
ECG Cable
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Then introduce the sterile items into the sterile field and connect them from the sterile
field:
¾
¾
¾
Sterile electrical umbilical
Sterile coaxial cable
CryoAblation catheter
Under no circumstances should any sterile coaxial or electrical umbilical be resterilized or re-used. All sterile products, once used, are to be discarded with
accordance to hospital procedures.
Should the customer or Medtronic CryoCath LP Technologies request that any accessory
be returned to Medtronic CryoCath LP for inspection, it must be disinfected, cleaned and
packaged as per Medtronic CryoCath LP Quality guidelines.
A Return Goods
Authorization (RGA) number is necessary and is distributed by Medtronic CryoCath LP
Customer Service. Non-sterile accessories should be cleaned with a dry cloth and stored
with the CryoConsole after use.
Only accessories provided by Medtronic CryoCath LP can be used with the
CryoConsole. Do not expose catheter or accessories to fluids or solvents.
Medtronic CryoCath LP
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TRM-002 MDT.2 CRYOCONSOLE – GEN IV
I.6
Rev-00
Technical Specifications
MDT.2 CryoConsole (REF# 103A2, 103E2, 104A2, 104E2)
Regulatory Approvals:
The MDT.2 CryoConsole Gen III reference (103A2 and 103E2) is a type
CF, 115/230v, 50/60Hz, 10A, with respect to electric shock, fire,
mechanical hazards in accordance with UL 2601-1:1994, CAN/CSA
C22.2 No. 601.1, IEC 601-01, and control number 75 HN.
The CryoConsole Gen IV reference (104A2 and 104E2) is a type CF
(defibrillation proof), 110/120/230v, 50/60Hz, 10A, with respect to electric
shock, fire, mechanical hazards in accordance with UL 2601-1:1997,
EN/IEC 60601-1, CAN/CSA C22.2 No. 601.1-M90 CSA file #220418.
MDD CLASS IIb - CE Mark Certificate of Conformity No: 0088/ LRQ
0959680
PMA approved device PO20045
MDL 32473 (Canada)
REF#
MDT.2 CryoConsole
After power up, normal operating parameters are:
NA: 110V±10% 10 amps
CE: 230V±10% 5 amps
At power up, the equipment could draw a transient current of 10% greater than the
nominal values
Operational Parameters:
103E2 /
103A2 /
104E2 /
104A2
15°C to 30°C (60°F to 86°F)
Maximum of 75% humidity
Altitude from sea level to 2400 meters (8000 feet)
Dimensions:
Gen III
Gen IV
Metric
Imperial
Metric
H: 127 cm
H: 50”
H: 157 cm
D: 82 cm
D: 32”
D: 58.5 cm
W: 54 cm
W: 21”
W: 54.6 cm
Weight:
Gen III
Gen IV
Metric
Imperial
Metric
Imperial
H: 62”
D: 23”
W: 21.5”
Imperial
145 kg
320 lbs
131 kg
289 lbs
(Without N2O tank)
(Without N2O tank)
(Without N2O tank)
(Without N2O tank)
Table 1 - CryoConsole Specifications
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Accessories
The ECG cable and auto connection box provide an interface between the Medtronic CryoCath
LP and a standard EP system (via 2mm touch proof connectors).
The scavenging hose is used to evacuate N2O from the CryoConsole to the hospital gasscavenging outlet.
The optional foot switch is a remote control to initiate and stop injection of refrigerant.
Copies of all the Regulatory Approvals are available upon request.
Medtronic CryoCath LP
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TRM-002 MDT.2 CRYOCONSOLE – GEN IV
REF#
Accessories
2037A
Auto connection box
2035W
103FS(GenIII)
104FS(GenIV)
ECG cable
Footswitch (optional)
Rev-00
Metric
L: 14 cm
W: 7 cm
H: 5 cm
Imperial
L: 5.5”
W: 2.5”
H: 1.8”
0.5 kg (approx.)
1.1 lbs. (approx.)
L: 81 cm
L: 32”
L: 17 cm
W: 15 cm
H: 2.5 cm
L: 6.5”
W: 6.0”
H: 1.0”
Cord Length:
6.7m
Cord Length:
12’
L (1035C): 20’
L (1035D): 25’
L (1035E): 30’
L (1035F): 40’
ID: 0.3”
OD: 0.55”
1035C
(1035CW)
1035D
(1035DW)
1035E
(1035EW)
1035F
(1035FW)
Yellow Scavenging hose
(White Scavenging hose)
L (1035C): 6.0 m
L (1035D): 7.5 m
L (1035E): 9.0m
L (1035F): 10.5m
ID: 0.75 cm
OD: 1.375 cm
1038N
Power cord North America
L: 2.5 m
L: 8’ 2”
1038E
Power cord EU
L: 2.5 m
L: 8’ 2”
1038U
Power cord UK
L: 2.5 m
L: 8’ 2”
1038Y
Power cord Italy
L: 2.5 m
L: 8’ 2”
Table 2 - Accessories Specifications
Refrigerant Tank
The refrigerant is liquid nitrous oxide (N2O).
¾
¾
European N2O refrigerant tank – REF # 103NE
North American N2O refrigerant tank – REF # 103N2
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The CryoConsole operates with a refrigerant tank that contains high-pressure liquid nitrous oxide
(N2O). Store and handle the nitrous oxide refrigerant tanks according to the hospital gas
storage/management policy. Exposure to nitrous oxide should be minimized to prevent shortterm behavioural and long-term reproductive health effects. Do not use Medtronic CryoCath LP
refrigerant tanks on any other equipment. Use only the N2O refrigerant tank obtained by
Medtronic CryoCath LP. The Threshold Limit Value (TLV) for nitrous oxide is 25ppm as
recommended by NIOSH, National Institute for Occupational Safety and Health.
N2O Specifications
Description: Cryogenic liquid nitrous oxide.
Molecular Formula: N2O (UN 1070) 99.5% liquid phase with humidity level less than 50ppm.
Gas Scavenging Requirements
The CryoConsole produces Nitrous Oxide (N2O) waste gas that should be removed from the
system. There are three options for scavenging. Selecting the appropriate scavenging method is
the hospital’s responsibility. Use only the scavenging hose obtained by Medtronic CryoCath LP.
Exhaust N2O to Vacuum Scavenging System (Active Scavenging)
This is the Medtronic CryoCath LP recommended method for removing waste gas. The
scavenging hose should be attached to a hospital evacuation or vacuum system. The hospital
system should meet the following requirements:
Gas to be scavenged .............................................................. Nitrous Oxide (N2O)
Scavenging refrigerant flow .................................................... 5000 sccm N2O
Scavenging vacuum level ....................................................... ≥ 15 in Mercury (Hg), or ≥ 380mm
Hg, or ≤ 7.4 psia, or ≤ 51 KPa
Scavenging hose length provided .......................................... approximately 6.1m/ 20’ up to
18.3m/ 60 ‘
Scavenging connector ........................................................... DISS (Some adaptors for common
connection systems are available)
Exhaust N2O into a Non-recirculating General Ventilation System (Passive Scavenging)
If a non-recirculating general ventilation system is present in the hospital, the discharge end of the
scavenging hose can be placed up in an exhaust vent and the N2O will be vented out of the
building. Care should be taken to ensure that the tubing is placed far enough into the duct
system to prevent the N2O from re-entering the room.
Exhaust N2O Directly to Outdoors (Passive Scavenging)
Since the gas is under positive pressure, the discharge end of the scavenging hose can be
exhausted directly outdoors. This can be accomplished by placing the end of the hose out a
window or attached to a pipe placed through a wall or ceiling to the outdoors. Care must be taken
to ensure that the discharge location is NOT an area where people are normally present or in
close proximity to an outside air intake or window where the N2O could re-enter the building. The
standard scavenging hose length provided by Medtronic CryoCath LP is 10.5m/40’ long. If a
longer hose is required, please contact Medtronic CryoCath LP Customer Service.
Medtronic CryoCath LP
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Section II Functional System Description
II.1
Purpose
The purpose of this section is to give a basic knowledge of the functional system of the MDT.2
CryoAblation System, therefore ensuring that appropriate actions are taken.
II.2
Scope
This section briefly describes the functional system of the CryoConsole, introducing the software
interface, the mechanical system, and the electrical system.
II.3
Definitions and Acronyms
The following definitions and acronyms are used in this section
MDT
EP
LCD
CDM
PID
CPU
ISA BUS
AC
DC
IDE
II.4
Medtronic CryoCath LP
Electrophysiology
Liquid Crystal Display
CryoAblation Data Manager
Proportional-Integral-Derivative
Central Processing Unit
Industry Standard Architecture BUS
Alternating current
Direct current
Integrated Drive Electronics
System Overview
The CryoConsole is a combination of mechanical assemblies controlled by electronic circuitry.
Control interfaces are available on the front and back panels of the unit allowing the system to be
integrated in EP Lab set-up.
The catheter electrical connection is fed to the system through an isolation interface located on
the patient board. This electrical interface provides a protection against electrical hazards and
protects the CryoConsole unit from defibrillator discharges.
The user interfaces with the CryoConsole through a LCD touch screen, two indicators and two
controls located on the front panel of the CryoConsole. The LCD touch screen shows a series of
menus for operation of the CryoConsole and display of relevant information. The user starts the
application of a procedure by pushing the hardware injection “ON” button for 2 seconds and stops
the procedure at any time by pressing the hardware injection “OFF” button.
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When the optional foot switch is in use, the user starts the application of a procedure by
depressing the footswitch for 2-3 seconds and stops the procedure at any time by depressing the
footswitch for 0.5 seconds.
The watchdog system is the focal point of any data sent and received either to or from the
software user interface. The watchdog system is the brain of the system control, which
continually monitors the mechanical assembly state, user requests and process failure and/or
warning detection. It also acts as an interface between the software/user and the mechanical
plumbing, which ensures patient and user safety should the software fail.
II.5
Software Interface
II.5.1. Software Interface Overview
The CryoConsole includes the software called CryoAblation Data Manager (CDM) and the
software called Boot Strap Module (v3.02 and above). The main role of the software is to acquire
and display system data from the hardware, set procedure parameters, save procedure data on
the system hard disk and offer some automatic operational features. At system start-up, the
software initiates a system self test which ensures proper functionality of the watchdog system
and other system and safety features. Should the self-test fail, the CDM disables the system in
order to prevent the user from proceeding.
II.5.2. Boot Strap Module
The role of the Boot Strap Module is to detect and authenticate software upgrade MDT diskettes
and then launch the upgrade. This application facilitates software upgrades without the need for
a field service representative intervention. This software is installed on CryoConsole depending
on the approved country of installation.
II.5.3. CryoAblation Data Manager (CDM)
From the main interface panel, the software provides four major functional areas for the user to
access: the CryoTherapy Panel, the Review Patient Records Panel, the Service System Panel
and the Shut Down System button.
Selecting the Begin CryoTherapy button brings up the Patient Data Panel where the patient
information is entered and saved to the hard disk. Through this panel, the user initiates a
CryoTherapy procedure.
When a CryoTherapy procedure is requested, the software ensures that a valid catheter is
connected to the CryoConsole. When it is connected, the CDM downloads a catheter
identification code stored on a smart chip located inside the catheter handle. The catheter code
is used to identify a catheter specific file located on the hard disk of the CryoConsole. This file
allows the software to program the user interface on the procedure panel and set their default
values, and contains parameters required for the proper operation of the identified catheter.
During a procedure, the software continuously displays relevant information on the screen. The
temperature profiles are saved to the hard disk for future recall. Data recording starts at the
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beginning of an injection and stops when the temperature reaches +10oC after stopping the
injection. This feature allows the recording of the temperature thawing profile.
If a warning or failure occur, the user is immediately notified. If a system failure is detected during
the procedure, the software stops saving the temperature profiles and opens a separate file
where it logs the current state of the system. This system state file contains the most recent 99
system failures.
Depending on the type of catheter connected, the CryoConsole controls the catheter in two
different ways:
Temperature Control (only during CryoMapping):
During a procedure, pressurized refrigerant is delivered in order to reach and maintain a
predetermined ablation temperature.
This continuous temperature control assures a
compensation for heat load changes due to the blood movement during cardiac cycles or due to
changes in the contact between the catheter tip and the tissue.
Temperature control is performed using two control loops: a hardware pressure control loop and a
software temperature control loop. The CDM controls the tip temperature by reading the current
tip temperature and determines the required delivery pressure set point using a special algorithm
based on digital proportional-integral-derivative (PID) compensator. The pressure set point is
sent to the hardware pressure controller, which assures a continuous control of a proportional
valve based on a pressure transducer reading.
Flow Control (for all catheters during CryoAblation):
During a CryoTherapy procedure, pressurized refrigerant is delivered to reach and maintain a
specific pre-determined flow value. This flow value ensures optimal tip temperatures required for
ablation. As in the temperature control case, two control loops are used: A hardware pressure
control loop and the software flow control loop. The CDM controls the refrigerant flow by reading
the flow meter and determining the required delivery pressure set point to maintain that flow using
a special algorithm based on digital proportional-integral-derivative (PID) compensator.
Should the CDM fail, a redundant hardware system is implemented as part of the Watchdog
system to monitor the pressure set point sent by the CDM. Furthermore, the Watchdog system
monitors the state of the CPU and the software in order to detect a freeze or abnormal loops and
takes action by placing the mechanical plumbing into a safe mode. Another important feature of
the Watchdog system is to block the analog set point controlled by the CDM whenever an
injection OFF is requested or a failure is generated.
If the Review Patient Records option is selected, a file manager panel is displayed. This allows
the user to select from a list of previously run procedures. The selected file may then be opened
for viewing, copied to a floppy disk, or deleted from the hard disk.
The third functional area, which can be selected from the main panel, is the Service System
Panel. This is to aid certified service personnel in performing routine system maintenance and to
help technical personnel in troubleshooting the system. To prohibit unauthorized personnel from
accessing restricted system information, several troubleshooting panels are password protected.
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The last functional area is the Shut Down System button. Before turning off the power of the
CryoConsole, make sure to wait until the message “It is now safe to turn off your computer” is
displayed on the screen.
II.5.4. Catheter Files
Each catheter used with the CryoConsole requires different settings of operations. Therefore, the
data for each catheter is stored in a catheter file. When a catheter is approved for use with the
CryoConsole, the associated catheter file is installed in the appropriate directory.
II.5.5. Hardware File
The CryoConsole uses a binary file called Hardware file which contain the necessary parameters
for interpreting analog signals including the appropriate tank formula for the calculation of
remaining N2O. The hardware file is dependant of the CDM software version and the CDM
software is configured to load the appropriate file based on the console configuration (North
American, European, or other).
II.6
Mechanical System
II.6.1. Mechanical System Overview
The mechanical assembly delivers a controlled pressurized refrigerant to the catheter, recovers
the refrigerant vapour from the catheter and evacuates the residual refrigerant from the catheter
at the end of the injection. The mechanical system can be split into the following three subsystems:
¾ Refrigerant delivery plumbing
¾ Refrigerant recovery system
¾ Refrigerant evacuation system
The delivery system uses liquid N2O as refrigerant, which is sub-cooled to an appropriate
temperature prior to being injected inside the catheter through the injection umbilical tube. The
system recovers the N2O vapour from the catheter and sends it to the hospital scavenging system
through a scavenging hose.
Electromechanical valves, pressure transducers and flow meter are used in order to control and
monitor the status of different areas of the mechanical assembly.
II.6.2. Pressure Transducers
A pressure transducer is a device that converts input pressure into low-level electrical/electronic
signals (volts).
In the CryoConsole, we use three pressure transducers. The first transducer is used to measure
the tank pressure. The second transducer is used to measure the pressure delivered by the
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proportional valve. That pressure is fed to the PID system that will be used as a feedback to
compensate and adjust the proportional valve according to either the temperature or the flow
(depending on the catheter used).
The third transducer is used to measure the pressure out of the catheter, thus verifying that N2O
gas is flowing out of the catheter and that no blockage occurs inside the catheter.
II.6.3. Regulators
A pressure regulator is a device that adjusts pressure at a desired value.
Since a pressure of 760 psig is enough to ablate at -75oC, we use two regulators, first to bring
down the pressure to 840 psig and second to bring it down to 810 psig.
II.6.4. Solenoid Valves
Solenoid valves are electro-mechanical devices that use a solenoid to control valve activation.
In the CryoConsole, there are five solenoid valves performing specific duties.
¾ The first valve is the injection solenoid valve turning on and off the injection circuit.
¾ The second valve is the switch
II.7
Electrical System
II.7.1. Electrical System Overview
The LCD touch screen and the front panel implement the user interface with the CryoConsole.
The LCD touch screen is a graphical user interface, which displays CryoConsole status, data and
accepts user data and control inputs via screen touches. The front panel consists of controls and
displays that show CryoConsole status.
The side IDE panel consists of a mouse, keyboard and analog connectors. The mouse and
keyboard connectors are connected to the CPU board through extension cables. Those
connectors should only be used by Field Service representatives. Also found on this panel
is an hour meter that indicates the number of hours the CryoConsole has been powered on. This
information is useful for maintenance purposes.
The 1.44 Mb floppy disk drive is mounted in the procedure panel and is used to download patient
data on disks and to upload upgrades to the CDM software and catheter identification files.
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II.7.2. Power Distribution
The power entry module with voltage selector, thermistors, slow blow fuses, line filter and power
switch are rated at 250V operating voltage. The power supply, isolation transformer and line filter
are rated at 50/60 Hz.
The voltage selector on the primary side of the isolation transformer is used to enable the
120v/240v conversion.
II.7.2.1. Thermistors
The thermistors are only installed on the power inlet cables of CryoConsole powered by 220V.
The thermistors purpose is to protect against any existing inrush current when the system is first
switched on.
Section III
Operation and Clinical Sequence
Please refer to the Operator’s Manual, its appendices, as well as the appropriate Instructions For
Use for the respective catheter.
Section IV
Troubleshooting and Maintenance
IV.1 Purpose
This section proposes troubleshooting steps to follow when the CryoConsole is not operating
correctly.
IV.2 Scope
This section is separated in two main sections. These sections are the maintenance and the
software interface.
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IV.3 Definitions and Acronyms
The following definitions and acronyms are used in this section
CDM
CPU
DAQ
FPGA
HDD
NIBBLE
CryoAblation Data Manager
Central Processing Unit
Data acquisition board
Field Programmable Gate Array
Hard Disk Drive
Four binary digits or half of a byte. A nibble can be conveniently
represented by one hexadecimal digit.
IV.4 Maintenance
In addition to act as an interface for the user, the CryoAblation Data Manager software installed
on the CryoConsole is an interface for the Field Service Representative during a maintenance
job.
The representative can access the maintenance section by touching the Service System button
located on the main panel, shown in Figure 7.
Some panels require the use of a keyboard attached to the maintenance panel above the N2O
cylinder. The connector type of the keyboard must be a type AT.
Figure 7 - Main panel
IV.4.1.
System Setup panel
This screen is used to monitor the tank level read by the load cell as well as the tank pressure
read by the pressure transducer. The user can return to the Main Panel by pressing the Return to
Main Panel button or access the System Maintenance panel by pressing the Advanced
Troubleshooting button. Figure 8 shows the System Setup panel.
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Figure 8 - System Setup panel
IV.4.2.
Password panel
When pressing the Advanced Troubleshooting button, the system notice #12303 - The
CryoAblation console maintenance should be done by a qualified person appears. The
CryoConsole requires a password to proceed. The low level access password is “user”.
Only trained service engineers will have access to all required passwords.
The user enters the password and presses Ok.
Figure 9 - Password panel
IV.4.3.
System Maintenance panel
In this panel, the user can choose between six different sections:
¾
¾
¾
¾
¾
Password Setup
Date & Time Setup
Touch Screen Setup
Site Setup
Back Up Patient Files
Figure 10 shows the System Maintenance panel.
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Figure 10 - System Maintenance panel
IV.4.4.
Password Setup panel
The purpose of this panel is to change the default password used to access the System
Maintenance panel. Figure 11 shows the Password Setup panel.
Do NOT change the password.
Figure 11 - Password Setup panel
IV.4.5.
Date & Time Setup panel
The Date & Time Setup panel allows the user to change the date and time of the CryoConsole.
Figure 12 shows the Date & Time Setup panel.
Figure 12 - Date & Time Setup panel
IV.4.6.
Touch Screen Setup panel
The purpose of this panel is to calibrate the touch screen when the precision is out of range.
When the user pushes on the Touch Screen Setup button, the system gives instructions on how
to calibrate the touch screen.
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IV.4.7.
Rev-00
Site Setup panel
The purpose of this panel is to:
¾ Choose the language of the CryoAblation Data Manager
¾ Enter the site name
¾ Update the physician, outcome and diagnosis list of the CryoAblation Data Manager
To set the language, select a language from the Language drop-down list.
To enter the site name, write the site name in the New Site text box and press the Update Site
button. This name will appear on the home screen after power-up.
To update one of the three lists, press the desired button (Physician, Outcome, Diagnosis), enter
the physician name, outcome or diagnosis in the text box, and press the Add button. To delete
an entry, select the entry in the list and press Delete. Refer to Figure 13.
Figure 13 - Site Setup panel
IV.4.8.
Back Up Patient File
The purpose of this panel is to make a back up of all the patient data currently stored on the hard
drive. When downloaded from this panel, the files are saved in binary format. These files should
be downloaded and sent to MDT on a regular basis.
Figure 14 - Backup Patient Files panel
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These files help us understand any problem encountered during an injection, see behaviors that
may have not appeared during an injection, and helps us identify any possible behavioural
patterns.
To download these files:
1) Navigate to the System Maintenance panel
2) Select Backup Patient Files
3) Insert a floppy disk in the floppy drive
4) Press Backup. The console will start downloading the patient files that have a check
mark to the floppy disk. As the files get saved on the floppy, the checkmark is removed.
The console may request you to change the disk if it gets full. The downloading process
is finished when all the checkmarks disappear and the green light on the floppy drive turns
off.
Green Light
Figure 15 - Floppy Drive
IV.5 Software Interface
IV.5.1.
General information
The CryoConsole includes software called CryoAblation Data Manager (CDM). The main role of
the CDM is to acquire and display system data from the hardware, set procedure parameters,
save procedure data on the system hard disk and offer some automatic operational features. At
system start-up, the software initiates a system self test which ensures proper functionality of the
watchdog system and other system and safety features.
Should the self-test fail, the CDM disables the system in order to prevent the user from
proceeding and displays a coded error message on the screen.
IV.5.2.
Power up test
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At start-up, CDM performs a series of tests to verify the CryoConsole hardware and proper
operation. If a test fails, two error codes are generated and displayed on the CryoConsole
screen.
The first series of power up tests is related to the software integrity, including the testing of the
system and configuration files. These files contain important information that could affect the
functionality of the system.
The second series of tests is related to the interface between the software and the hardware.
These tests verify the proper operation of the data acquisition, digital and analog input/output
lines. The data acquisition test is crucial to the performance of other tests; if this test fails, the
remaining tests are not performed.
The third series of tests is related to the functionality of the FPGA and the functionality of major
safety features. The FPGA component is part of the Watchdog board.
IV.5.3.
CDM Codes and Messages
The CDM software uses codes and messages to inform the user the status of the CryoConsole.
Always note the message number before calling Technical Support in order to resolve the issue
faster.
IV.5.3.1.1. System notice hierarchy
A message to the user is called a system notice. That system notice can be of four
different types, depending on the message content. Starting from the least important and
going to the most important messages are the notice, caution, the warning and the
danger. They respectively are blue, yellow, orange and red. Depending on the source of
the notice, the software will assign a different importance to this notice.
To prevent the user from missing a system notice, the first screen appearing to the user is
the Message List notice showing all of the system notices. Figure 16 shows the Message
List screen
Figure 16 - Message List
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The system notices includes a different presentation of the information. It presents the
notice with three distinctive fields: Problem, Consequence and Action. Figure 17 and
Figure 18 show the four notice types.
A blue notice is for information only and no action is required in order to get into the
Therapy panel and start and injection.
A yellow notice requires an action in order to go into the Therapy panel.
An orange notice is a failure that will stop an injection or prevent the user from starting
one. This notice can be reset and no immediate action needs to be taken.
A red notice is a critical console failure that will cause the termination of the procedure.
The console needs to be shutdown and Medtronic CryoCath LP Technical Support must
be informed.
Figure 17 - Danger and Warning System Notice
Figure 18 - Caution and Notice System Notice
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The notices are part of a numbered series. Table 3 shows the numbered series in relation
with the source of the notice.
Series
10000
11000
12000-13000-14000
15000
16000
17000
18000
19000
20000
21000
22000-23000-24000-25000
50000
60000
Source of the notice
Language confirmation panel
System Start-up Failure
System Warning
File Reading Error
Disk Space
File Writing Error
System Alert
System Error
Directory Error
System Self Test Failure
Message Panel
Hardware Failure
Hardware Warning
Table 3 - Notice series
IV.5.3.1.2. Hardware System Notice
The hardware system notices are the most common errors that are seen in the field while
troubleshooting a problem. The watchdog board is the hardware responsible for triggering
a hardware failure or a hardware warning. The associated system notices are the 50000
and 60000 series notices.
Whenever the console fails the Power up test, it will give you yellow system notice,
#11200, saying “There is a problem with the system Error1: X-X-X Erro2: Y-Y-Y). Be sure
to note these two error numbers before calling Technical Support.
Table 5 in Appendix A– System Notices shows all of the system notices, the problem,
the consequence and recommended action. Table 6 in Appendix B– Additional
Warning Messages shows warning messages not included in the system notices.
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Appendix A– System Notices
.
Notice
Problem
Consequence
Action
Description
10300
The language you selected
is not currently available.
The language was not
changed.
Select a different
language.
Language selected is not
currently available
11200
There is a problem with the
system
(Error1: X, Error2: Y)
You cannot continue the
procedure.
Shut down the system and
restart it. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Shutdown system and call
service technician. Error1
= X Error2 = Y
12200
There is a problem with the
system.
You must take action in
order to continue the
procedure.
12201
There is a problem with the
system.
You must take action in
order to continue the
procedure.
There is a problem with the
system file.
There is a problem with the
system file.
You cannot continue the
procedure.
You cannot continue the
procedure.
12204
There is a problem with the
catheter file.
You cannot use the
catheter.
12205
There is a problem with the
catheter
You must take action in
order to continue the
procedure.
12206
The catheter may be
outside the patient, causing
the catheter tip temperature
to be too low.
You must take action in
order to continue the
procedure.
12300
There is a problem with the
language library: (%s)
The language setting has
changed back to English.
12301
There is a problem with the
system file.
The system functionality is
limited.
12202
12203
Disconnect the electrical
umbilical cable from the
catheter and then
reconnect it. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Disconnect the electrical
umbilical cable from the
catheter and then
reconnect it. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Call Medtronic CryoCath
LP customer service.
Call Medtronic CryoCath
LP customer service.
Disconnect the catheter
and reconnect it. If the
problem persists, call
Medtronic CryoCath LP
customer service.
Disconnect the catheter
electrical umbilical cable
and reconnect it. If
problem persists, replace
the catheter.
Check the catheter
placement.
Try selecting the language
again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Install or create a new
system file.
12302
There are no messages
Click Ok to continue
12303
The CryoAblation console
maintenance should be
done by a qualified person.
Click Ok to continue
The system could not save
the password.
The password was not
changed.
Try to change the
password again. If the
problem persists, call
Medtronic CryoCath LP
customer service.
There is a problem with the
message file.
The system could not save
You cannot view the
messages.
The language was not
12304
12305
12306
Medtronic CryoCath LP
You are not able to
continue the procedure,
Flow detection initialization
error
Flow Curve Programming
Error (Faulty
Tank/Temperature
programming)
Incompatible System File
Incompatible Failure File
Invalid Catheter Data File
Catheter Compatibility /
Integrity
Unacceptable catheter use
/ Catheter Compatibility
Can't load language
library, Library Name
System file error
The Failure Database is
empty
The CryoAblation console
maintenance should be
done by a qualified person.
Field Password Saving
Error
Click Ok to continue.
Failure file not found
Select a different
Error Saving Language
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TRM-002 MDT.2 CRYOCONSOLE – GEN IV
Notice
Rev-00
Problem
Consequence
Action
Description
your language selection.
changed.
Code
12307
There is a problem with the
configuration file.
The system could not save
the temperature calibration
parameters.
12308
The system could not open
the patient file.
You cannot view the
patient file.
12309
The system could not open
the patient file.
You cannot view the
patient file.
12310
The system could not open
the patient file.
You cannot view the
patient file.
12311
The system could not open
the patient file.
You cannot view the
patient file.
12312
The patient file is empty.
language, or install or
create a new configuration
file.
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Call Medtronic CryoCath
LP customer service.
Install or create a new
messages file.
Install or create a new
configuration file.
12313
12314
12315
There is a problem with the
message file.
There is a problem opening
the configuration file.
There is a problem with the
catheter file.
You cannot view the
patient file.
The system cannot update
the file.
The system cannot update
the file.
The system cannot load
the catheter parameters.
You cannot continue
without entering a catheter
name.
12316
The catheter name field is
empty.
12317
The temperature has not
yet reached 20-30 degrees.
You cannot calibrate the
temperature yet.
12318
There is an error copying
the patient file.
You cannot copy the
patient file to diskette.
12319
There is an error copying
flow curve data.
You cannot copy the flow
curve data to diskette.
12320
The patient name field is
empty.
You cannot continue
without entering a patient
name.
12321
There is no diskette in the
drive.
12322
Catheter file copying error:
%s
Cannot copy catheter file
to the floppy
12323
There is a problem with the
catheter file %s.
You cannot use the
catheter.
13300
The system cannot load the
touch screen calibration
file.
You cannot calibrate the
touch screen.
Medtronic CryoCath LP
Delete this file.
Enter the catheter name.
Calibration Saving Error
Patient file not found
Patient file Empty (file
check code is incorrect)
Patient Record Reading
Error (Pt file cannot be
opened)
Invalid Patient File (file
check code is incorrect)
Patient Record Empty
Failure file error
(setcdmver)
Configuration file error
(setcdmver)
Invalid Catheter Data File,
Please delete it
Please enter Catheter
Name
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
If the problem persists,
contact Medtronic
CryoCath LP customer
service.
Temperature calibration
can not be performed,
Please check patient board
temperature
File copying error, General
input output error with the
following (patient
Filename)
File copying error, General
input output error with the
following (flow curve data
Filename)
Enter the patient's name in
order to continue.
Please enter patient name
in order to continue
Insert a diskette and press
Ok.
Try again, and if problem
persists call Medtronic
CryoCath LP customer
service
Disconnect the catheter
and reconnect it. If the
problem persists, call
Medtronic CryoCath LP
customer service.
No disk in the floppy drive,
Please insert a disk
File copying error.
General input output error
with the following
(Filename)
Wait until the board
reaches the appropriate
temperature.
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Catheter file error.
Following file is not a valid
catheter file (filename)
Could not load Calibration
Library
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TRM-002 MDT.2 CRYOCONSOLE – GEN IV
Notice
Problem
Consequence
You cannot continue
without entering a console
ID.
You may not be able to
complete another
procedure.
14300
The console ID is empty.
14301
The hard drive is almost
full.
15300
There is a problem finding
the file.
You cannot copy the file to
diskette.
15301
There is a problem finding
the file.
You cannot copy the file to
diskette.
15302
There is a problem copying
the file.
You cannot copy the file to
diskette.
15303
There is a problem copying
the file.
You cannot copy the file to
diskette.
15304
There is a problem finding
the file.
You cannot copy the file to
diskette.
15305
There is a problem copying
the file.
You cannot copy the file to
diskette.
16300
16301
There is no diskette in the
drive.
There is not enough space
on the diskette.
Action
Description
Enter the console ID now.
Console ID is not set yet,
Please, do it now
Free some space on the
hard drive before the next
procedure.
The hard disk is almost
full, Free some space
before the next procedure
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Insert a diskette and press
Ok.
Insert another diskette and
press Ok.
17300
There is a problem copying
the file.
You cannot copy the file to
diskette.
17301
There is a problem copying
the file.
You cannot copy the file to
diskette.
17302
There is a problem copying
the file.
You cannot copy the file to
diskette.
17303
There is a problem copying
the file.
You cannot copy the file to
diskette.
17304
There is a problem copying
the file.
You cannot copy the file to
diskette.
17305
There is a problem copying
the file.
You cannot copy the file to
diskette.
17306
There is not enough space
on the diskette.
18300
There is a problem with the
Medtronic CryoCath LP
Rev-00
You cannot continue the
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
To continue, insert another
diskette and press Ok.
Otherwise, press Cancel.
Shut down the system and
File not found or directory
in path not found (copy fail
file, pt db, conv ptdb)
File not found, please
remove disk (copy cath db)
General I/O error occurred
(copy fail file, mkdir, copy
conv ptdb)
Insufficient memory to
complete operation (copy
fail file, mkdir, copy conv
ptdb)
Invalid path (copy fail file)
Access denied (copy fail
file & ptdb)
No disk in the floppy drive,
Please insert a disk
Not enough disk space,
Change disk
One of the path
components not found
(Copy ptdb & MkDir)
General I/O error occurred
Insufficient memory to
complete operation
Invalid path
Access denied
Specified path is a
directory, not a file.
Disk is full (w/ chg disk in
Archive & ConvDb)
You are not able to
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Notice
Rev-00
Problem
Consequence
Action
Description
system.
procedure.
restart it. If the problem
persists, call Medtronic
CryoCath LP customer
service.
continue the procedure,
Reboot System
19300
There is a problem copying
the file.
You cannot copy the file to
diskette.
19301
There is a problem finding
the file.
You cannot copy the file to
diskette.
19302
There is a problem finding
the file.
You cannot copy the file to
diskette.
19303
There is a problem copying
the file.
You cannot copy the file to
diskette.
19304
There is a problem copying
the file.
You cannot copy the file to
diskette.
19305
There is a problem copying
the file.
You cannot copy the file to
diskette.
19306
There is a problem copying
the file.
You cannot copy the file to
diskette.
20300
There is a problem copying
the file.
You cannot copy the file to
diskette.
20301
There is a problem copying
the file.
You cannot copy the file to
diskette.
20302
There is a problem copying
the file.
You cannot copy the file to
diskette.
20303
There is a problem finding
the file.
You cannot copy the file to
diskette.
20304
There is a problem copying
the file.
You cannot copy the file to
diskette.
20305
There is a problem copying
the file.
You cannot copy the file to
diskette.
21200
There is a problem with the
system.
You cannot continue the
procedure.
22400
System Shut Down
Please wait while your
Medtronic CryoCath LP
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Shut down the system and
restart it. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Access to floppy disk is
denied, check disk (copy
fail file and conv db)
File not found or directory
in path not found
General I/O error occurred
Insufficient memory to
complete operation
Invalid path (for either of
the file names).
Specified source path is a
directory, not a file (copy
fail file)
Disk is full
One of the path
components not found
General I/O error occurred
Insufficient memory to
complete operation
Invalid path
Access denied
Disk is full
You are not able to
continue the procedure,
Call a service technician
Please wait while your
Page 34 of 41
TRM-002 MDT.2 CRYOCONSOLE – GEN IV
Notice
Problem
Consequence
22402
Target Temperature Not
Attained
System Shut Down
system shuts down
Minimum temperature is
warmer than %d °C
Please close gas tank
22403
System Startup
22401
Rev-00
Action
Make sure the refrigerant
tank has been opened.
Catheter integrity test,
injection will be enabled
shortly.
System self test - Please
wait ...
Refilling Reservoir,
injection will be enabled
shortly.
22500
22501
22502
Injection will be enabled in
X seconds
System Startup - Self test
delay
23300
Are you sure you want to
exit?
If you exit, the system will
close this patient file. As a
result, you would not be
able to continue this
patient's procedure and
would have to create a
new patient file.
23301
The patient file will not fit on
one diskette.
You will need multiple
diskettes.
To continue, press Ok.
Otherwise, press Cancel.
23302
Are you sure you want to
end the procedure?
If you end procedure, the
system returns to the main
screen and closes the
patient file.
To end the procedure,
press yes. Otherwise,
press No.
23400
File Delete
Are you sure you want to
delete the file?
23401
System Shut Down
23402
Patient Database
23403
Temperature Calibration
23404
Catheter File Database
23405
Analog Data
24300
There is not enough space
on the diskette.
Error in File Selection
25401
Copy Failed
Click Ok to retry, otherwise
click Cancel and copy
'c:\\cryosys\\system\\Analo
Are you sure you want to
exit from this panel ?
Not enough disk space,
You will need multiple
disks, do you wish to
continue? (Conv db copy
to disk)
End Procedure, By ending
the procedure you will
return to the main screen
and close the patient file.
Are you sure you want to
end the procedure?
(Response to user
selecting abort in failure
panel)
File Delete, Are you sure
you want to delete the file?
(pt db)
System Shutdown, Are you
sure you want to quit?
Database Conversion,
Database already exists,
overwrite?
System Saving, Are you
sure you want to save
these data?
Warning, Do you want to
overwrite the existing file
(Overwriting catheter file)
Overwrite analog data file
To continue, insert another
diskette and press Ok.
Otherwise, press Cancel.
25400
Medtronic CryoCath LP
To exit, press Yes.
Otherwise, press No.
Are you sure you want to
quit?
This patient file already
exists. Do you want to
overwrite it?
Are you sure you want to
save the temperature
calibration?
This catheter file already
exists. Do you want to
overwrite it?
Overwrite the existing
analog data file?
Click Ok to retry, otherwise
click Cancel and copy
'c:\\cryosys\\system\\Analo
gData.txt' manually
Description
system shuts down
Minimum temperature is
warmer than X °C
Please close gas tank
Make sure the refrigerant
tank is opened 2 turns
counter clockwise
Change disk then press
Ok//Conv or archive, ok to
continue else cancel
Error in File Selection,
Click OK to Retry or
Cancel and copy
c:\cryosys\system\AnalogD
ata.txt manually
Copy Failed, Click OK to
Retry or Cancel and copy
c:\cryosys\system\AnalogD
Page 35 of 41
TRM-002 MDT.2 CRYOCONSOLE – GEN IV
Notice
Problem
Consequence
Rev-00
Action
gData.txt' manually
50000
50001
The electrical umbilical
cable is not connected
properly.
The vacuum is disabled
due to a problem with the
coaxial umbilical cable.
Injection has stopped. You
must take action in order to
continue the procedure.
Injection has stopped. You
must take action in order to
continue the procedure.
You must take action in
order to continue the
procedure.
Injection has stopped. You
must take action in order to
continue the procedure.
Injection has stopped. You
must take action in order to
continue the procedure.
Injection has stopped. You
must take action in order to
continue the procedure.
50002
The coaxial umbilical cable
is not connected properly.
50003
The pressure is low in the
system.
50005
Catheter leak is detected.
50006
Blood is detected inside the
catheter handle
50007
There is fluid in the
console.
You cannot continue the
procedure.
50008
There is a problem with the
system.
Injection has stopped.
50009
There is a problem with the
system.
Injection has stopped.
50010
There is a problem with the
system and the
temperature could drop
below acceptable limits.
You must take action in
order to continue the
procedure.
50011
The path of the refrigerant
is obstructed.
Injection has stopped. You
must take action in order to
continue the procedure.
50012
The path of the refrigerant
is obstructed.
Injection has stopped. You
must take action in order to
continue the procedure.
50013
The refrigerant level is too
low to continue.
You cannot continue the
procedure.
50014
There is a problem with the
console.
You must take action in
order to continue the
procedure.
50016
The CryoMapping
temperature exceeded the
PRESET range of
Injection has stopped. You
must take action in order to
continue the procedure.
Medtronic CryoCath LP
Description
ata.txt manually
Disconnect both ends of
the electrical umbilical
cable and reconnect them.
Disconnect both ends of
the coaxial umbilical cable
and reconnect them.
Disconnect both ends of
the coaxial umbilical cable
and reconnect them.
817 Vacuum connection
failure
Ensure refrigerant tank is
open.
819.1Low gas pressure X
psi, ensure refrigerant tank
is open
Replace the catheter
821 Catheter leak is
detected
Replace the catheter
822 Blood is detected
inside the catheter handle
The system is inoperable.
Please shut it down and
call Medtronic CryoCath
LP customer service.
Try again. If the problem
persists, shut down the
system and restart it. If
there is still a problem, call
Medtronic CryoCath LP
customer service.
Try again. If the problem
persists, shut down the
system and restart it. If
there is still a problem, call
Medtronic CryoCath LP
customer service.
Disconnect the catheter
electrical umbilical cable
and reconnect it. If
problem persists, call
Medtronic CryoCath LP
customer service.
Disconnect the coaxial
umbilical cable from the
console, make sure that
the port it was attached to
is clear of obstruction, and
reconnect the coaxial
umbilical cable to the
console.
If problem persists, replace
the coaxial umbilical cable.
If there is still a problem,
replace the catheter.
Replace the refrigerant
tank.
Try again. If the problem
persists, shut down the
system and restart it. If
there is still a problem, call
Medtronic CryoCath LP
customer service.
Position the catheter tip so
that it makes better contact
with the tissue.
816 Catheter electrical
connection failure
Baseline Flow
823 Fluid is detected
inside console vacuum line
824 Software Failure
825 Failure has been
initiated by the CPU.
826Temperature
Threshold programming
819.2 Ensure the inside of
console coaxial port is
clear
819.3 Ensure integrity of
refrigerant path in
catheter/umbilical
829 Refrigerant level
failure
830 Sub cooler
compressor failure
832 Improve catheter tiptissue contact
Page 36 of 41
TRM-002 MDT.2 CRYOCONSOLE – GEN IV
Notice
Problem
Consequence
Rev-00
Action
Description
temperature.
50017
The console is running hot.
Injection has stopped. You
cannot continue the
procedure.
50018
The refrigerant is not cold
enough.
Injection has stopped. You
cannot continue the
procedure.
50021
Problem with scavenging
Injection stopped. You
must take action in order to
continue the procedure.
50022
There is a problem with the
console
You must take action in
order to continue the
procedure
50024
There is a problem with the
refrigerant vent.
You must take action in
order to continue the
procedure.
50025
There is a problem with the
injection process.
Injection will not start. You
must take action in order to
continue the procedure.
50026
There is a problem with the
injection process.
Injection has stopped.
You must take action in
order to continue the
procedure.
50027
There is a problem with the
injection process.
Injection has stopped. You
must take action in order to
continue the procedure.
50028
There is a problem with the
injection process.
Injection has stopped. You
must take action in order to
continue the procedure.
50029
There is too much
refrigerant flowing.
50030
There is too much
refrigerant flowing.
50031
There is a problem with the
injection process.
60000
The coaxial umbilical cable
is not connected properly.
60001
The electrical umbilical
cable is not connected
Medtronic CryoCath LP
Injection has stopped. You
must take action in order to
continue the procedure.
Injection has stopped. You
must take action in order to
continue the procedure.
Injection has stopped. You
must take action in order to
continue the procedure.
You must take action in
order to continue the
procedure.
You must take action in
order to continue the
Check whether the fans
are working. Shut down
the system and wait 10
minutes before restarting
it. If the problem persists,
call Medtronic CryoCath
LP customer service.
Wait 10 minutes before
continuing the procedure.
If the problem persists, call
Medtronic CryoCath LP
customer service.
Ensure that the hospital
scavenging system is
turned on and that the
scavenging hose is
securely attached.
Try again. If the problem
persists, shut down the
system and restart it. If
there is still a problem, call
Medtronic CryoCath LP
customer service.
Disconnect the coaxial
umbilical cable from the
console and make sure
that the port it was
attached to is clear of
obstruction. Make sure
there is no obstruction in
the catheter or coaxial
umbilical cable, and
reconnect it.
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Replace the coaxial
umbilical cable.
Position the catheter tip so
that it makes better contact
with the tissue.
Try again. If the problem
persists, call Medtronic
CryoCath LP customer
service.
Disconnect both ends of
the coaxial umbilical cable
and reconnect them.
Disconnect both ends of
the electrical umbilical
833 Console temperature
is high
834 Refrigerant
temperature is high
837 Scavenging system
failure
838 Vacuum pump failure
840 Vent system failure
841 User Request backup
interface failure.
842 Injection valve (S1)
failure.
843 Vent valve (S2) failure.
844 Vacuum valve (S3)
failure.
820.1 Change coaxial
umbilical
820.2 Improve catheter tiptissue contact
847 Vent valve (S6) failure.
848 Baseline Flow
849 Check electrical
connector
Page 37 of 41
TRM-002 MDT.2 CRYOCONSOLE – GEN IV
Notice
60002
60003
60004
Rev-00
Problem
Consequence
Action
properly.
The vacuum is disabled
due to a problem with the
coaxial umbilical cable.
procedure.
You must take action in
order to continue the
procedure.
You may run out of
refrigerant
cable and reconnect them.
Disconnect both ends of
the coaxial umbilical cable
and reconnect them.
Low refrigerant level
Problem with scavenging
You must take action in
order to continue the
procedure.
Description
850 Check vacuum
connector
Replace refrigerant tank
851 Check refrigerant tank
level
Ensure that the hospital
scavenging system is
turned on and that the
scavenging hose is
securely attached.
852 Check scavenging
system
Table 5- System Notices
Medtronic CryoCath LP
Page 38 of 41
TRM-002 MDT.2 CRYOCONSOLE – GEN IV
Rev-00
Appendix B– Additional Warning Messages
WARNING Messages
Check refrigerant tank level
Check mechanical connectors
Possible Corrective Action
• Verify the cylinder level and cylinder
pressure in the system set-up panel.
• Center the cylinder on the plate support
(Load Cell).
• Verify the hose connection has no bends
or kinks.
• Verify the actual cylinder weight, using a
hospital’s calibrated scale.
• Replace the cylinder after completion of
the procedure.
• Verify the coaxial connections
• Replace the coaxial umbilical
• Replace the catheter
Note: This animation can occur in the patient
screen when the baseline flow is
around the threshold value of 100
sccm. This usually means there is a
leak in the system or the flow meter
needs to be calibrated.
Vacuum Connection Panel
Electrical Connector Animation
Scavenging Connector Animation
Upon pressing “OK” field and the warning
persists:
• Verify coaxial connections, then “OK”. If
the warning persists,
• Replace the coaxial umbilical, then “OK”.
If the warning persists,
• Replace the catheter
•
•
•
•
Verify the electrical connections
Replace the ECG box
Replace the Electrical Umbilical
Replace the catheter
• Verify the scavenging connection at the
CryoConsole and wall outlet.
• Verify the hospital’s scavenging system is
working (in case of an active system).
Table 6- Warning messages corrective action
Medtronic CryoCath LP
Page 39 of 41
TRM-002 MDT.2 CRYOCONSOLE – GEN IV
Rev-00
Appendix C– Guideline & Specifications for N2O refilling
¾ The refrigerant to be refilled is N2O (UN 1070) 99.5% liquid phase with a humidity level
less than 50ppm. It is important that the refiller supply the user with a “Certificate of
Analysis” (at each refilling), which would provide proof that the refilled refrigerant met or
exceeded the specifications indicated above. It is also important that the ‘Certificate of
Analysis’ refers to the gas quality after it has been put into the refrigerant tank.
¾ The refrigerant must be refilled in the supplied Medtronic CryoCath LP N2O tank. The
approximate amount of refrigerant to refill is 10lbs for North America and 8.3lbs for
Europe. These tanks consist of three (3) parts: cylinder, dip-tube and valve. It is
important that the gas supplier be aware of the stainless steel dip-tube. The gas supplier
must connect to the N2O tank valve outlet connector “CEODEUX C10500275”.
¾ Provided that the gas refiller has the proper equipment and adaptors to attach to the
Medtronic CryoCath LP N2O tank and that they provide an appropriate Certificate of
Analysis on the refrigerant quality specifications, then it is acceptable for Medtonic
customers to obtain their N2O tank refilled by a supplier of their choice.
¾
All parties handling the refrigerant tanks must be aware that when the N2O tanks have
any refrigerant in them at all they are considered to be containing dangerous goods
(I.A.T.A Class 2.2 Non Flammable, Non-toxic Gas and Class 5.1 Gases Oxidizer) and
should be handled accordingly.
Medtronic CryoCath LP
Page 40 of 41